The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.
The EMA’s Committee for Medicinal Products for Human Use has issued positive opinions for multiple aflibercept and ustekinumab biosimilars, intensifying competition for Eylea and Stelara respectively in Europe. Meanwhile, a Biocon subsidiary also received a nod for a Neulasta biosimilar.
In a further setback for generics manufacturers, the District Court of The Hague has upheld the validity of a key Xtandi (enzalutamide) patent and its Dutch supplementary protection certificate, rejecting Sandoz and Accord’s challenge based on lack of inventive step.
As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.
Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Tevogen is looking to accelerate its growth with a major expansion of its headquarters in Warren, New Jersey, more than doubling its footprint to centralize research and development, regulatory, and corporate functions. The new facility will support the company’s evolving initiatives.
In an exclusive interview, Meitheal Pharmaceuticals CEO Tom Shea discusses the company’s oncology strategy following the recent launch of generic Abraxane, alongside discussion of complex injectables, the biosimilars pipeline, and how $300m in backing is fueling the company's next phase of growth.
As it prepares to complete its $6.7bn merger with Mallinckrodt, Endo has divested its International Pharmaceuticals business – consisting primarily of Canadian specialty firm Paladin Pharma – to Knight Therapeutics.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.
Teva has agreed to partner with China’s Fosun Pharma to develop TEV-56278, a targeted cancer immunotherapy, marking the next step in its continued pivot from its generics roots toward complex biologics and innovative oncology treatments. The deal covers key Asian markets, including mainland China, w
The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.
Sun’s founder hands top job to company longtimer Kirti Ganorkar as the firm implements a “structured and forward-looking” succession plan, while Richard Ascroft will lead the Indian drugmaker’s North America business.
In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.
Lupin is planning to expand its footprint in China through a deal for a tiotropium dry powder inhaler with local player Sino Universal Pharmaceuticals.
Outlook Therapeutics has started to conquer European markets with its ophthalmic version of bevacizumab. Meanwhile, across the pond in the US, it awaits the FDA’s decision, again.
As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.
Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.
After signing a deal with Avenacy at the end of last year, Hyloris has now announced the approval of its intravenous formulation of tranexamic acid, which is used as a hemostatic agent.